Status:
COMPLETED
Evaluation of Accuracy of CFD-based RuiXin-FFR by Comparing With Pressure-wire-based FFR
Lead Sponsor:
Beijing Anzhen Hospital
Conditions:
Coronary Artery Disease
Myocardial Ischemia
Eligibility:
All Genders
18+ years
Brief Summary
Coronary Artery Disease (CAD) is the top killer nowadays. Pressure-wire-based Fractional Flow Reserve (FFR) is the gold standard for measuring ischemia in coronary arteries. CFD-based RuiXin-FFR, whic...
Detailed Description
The participants are entered with suspended CAD and angiography ischemia between 30%-90% from 6 hospitals in China. Pressure-wire-based FFR is conducted in the standard protocol by each hospital. FFR\...
Eligibility Criteria
Inclusion
- able to understand the purpose of the study and sign the informed consent
- with diagnosed or confirmed coronary artery disease according to the comprehensive clinical assessment
- with CTA image indicating that the diameter of the reference vessel in the stenosis segment was ≥2mm
- with CTA image indicating that the stenosis degree of coronary artery lumen diameter ≥30% and ≤90%
Exclusion
- prior coronary artery bypass bypass (CABG) surgery, coronary interventional therapy (PCI), artificial heart valve implantation, cardiac pacemaker or implantable defibrillator implantation
- persistent or active symptoms of clinical instability, including acute chest pain (sudden onset), cardiogenic shock, unstable blood pressure status (systolic pressure less than 90 mmHg), severe congestive heart failure (NYHA grade III or IV), or acute pulmonary edema
- acute myocardial infarction occurred within 7 days before inclusion
- complex congenital heart disease, sick sinus syndrome, long QT syndrome, severe arrhythmia, tachycardia, severe asthma, severe or very severe chronic obstructive pulmonary disease (COPD) and chronic renal damage (serum creatinine value \> 1.5 mg/dl or creatinine clearance \< 45 ml/Kg\*1.73 m2)
- there are contraindications for the use of adenosine disodium triphosphate
- allergic to iodized contrast media
- pregnancy or pregnancy status unknown
- life expectancy less than 2 months
- there are any factors that other researchers consider not suitable for inclusion or completion of this study
- obvious mismatch of coronary artery CTA images
- CTA image showing calcification occupies the cross-sectional area of the lumen \> 80%
- CT value standard deviation of aortic root image \>30HU
- coronary artery occlusion.
Key Trial Info
Start Date :
March 13 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 31 2020
Estimated Enrollment :
316 Patients enrolled
Trial Details
Trial ID
NCT04731285
Start Date
March 13 2019
End Date
August 31 2020
Last Update
September 5 2021
Active Locations (1)
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1
Shaoping Nie
Beijing, China